Simdax 12.5 mg/5 ml
Simdax 12.5 mg/5 ml is a medicine authorised by Swissmedic under authorisation number 62463. The authorisation holder is Orion Pharma AG. The medicinal product code is Synthetic medicines and the dispensing category is A: Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly. First authorisation was granted on 04 November 2013 and the authorisation is valid without a time limit. ATC code C01CX08 places the medicine in the group Cardiac therapy.
| Authorisation number | 62463 |
|---|---|
| Name | Simdax 12.5 mg/5 ml |
| Full name | Simdax 12.5 mg/5 ml, Konzentrat zur Herstellung einer Infusionslösung |
| Authorisation holder | Orion Pharma AG |
| Medicinal product code | Synthetic medicines |
| Dispensing category | A · Prescription, not repeatable |
| ATC code | C01CX08 |
| First authorisation | 04 November 2013 |
| Authorisation validity | unlimited |
| No. | Name | Dispensing category | Authorisation date |
|---|---|---|---|
| 1 | Simdax 12.5 mg/5 ml, Konzentrat zur Herstellung einer Infusionslösung | A | 04 November 2013 |
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| Pack code | Quantity | Unit | ATC | IT code | Dispensing category |
|---|---|---|---|---|---|
| 1 | 1 x 5 ml | Durchstechflasche(n) | C01CX08 | 02.05.2. | A |
| 2 | 4 x 5 ml | Durchstechflasche(n) | C01CX08 | 02.05.2. | A |
| 3 | 10 x 5 ml | Durchstechflasche(n) | C01CX08 | 02.05.2. | A |
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Medicines in the same ATC group
Other medicines from this authorisation holder
Frequently asked questions
Is Simdax 12.5 mg/5 ml authorised in Switzerland?
Yes. Simdax 12.5 mg/5 ml is authorised by Swissmedic under authorisation number 62463, data as of 01 September 2026. The authorisation is valid without a time limit.
Which dispensing category does Simdax 12.5 mg/5 ml have?
Simdax 12.5 mg/5 ml is in dispensing category A. Supplied only against a medical or veterinary prescription that may not be dispensed repeatedly.
Who is the authorisation holder of Simdax 12.5 mg/5 ml?
The authorisation holder is Orion Pharma AG. The holder carries the legal responsibility for quality, safety and product information of the medicine in Switzerland.
Sources
Swissmedic data as of 01 September 2026. No medical advice. Independent directory, not affiliated with Swissmedic or the FOPH.